Anatomical Determinants and Outcomes of Small Annulus Patients Undergoing TAVR in Different ASIAN Ethnicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Transcatheter aortic valve implantation (TAVI) presents unique challenges for Asian patients compared to Caucasians, largely due to the prevalence of small aortic annulus (SAA) defined based on Caucasians' data (430 mm²), bicuspid aortic valve (BAV), and substantial calcium deposits. No universally accepted cutoff value for defining SAA exists among Asian patients, who tend to have smaller body-built, resulting in inconsistencies across various studies. For the new-generation 20-/23-mm balloon expandable valve, a SAA is categorized as \<330 mm². Additionally, Asian Japanese patients have been identified to have extremely SAA (\<314 mm²), associated with unexpectedly larger residual transvalvular gradients following TAVI. Previous research on patient prosthesis mismatch (PPM) impact within the Asian population has also shown inconsistency. The OCEAN-TAVI registry with 1,546 Japanese patients found no significant differences in one-year all-cause and cardiovascular mortality between PPM and non-PPM groups. A study on the Sapien 3 balloon expandable valve in patients with SAA (\<430 mm²) found comparable clinical outcomes to non-SAA patients up to five years post-procedure, consistent with findings from a South Korean study. However, a Taiwan study involving 201 patients with PPM indicated higher rates of adverse outcomes at mid-term follow-up. Moreover, TAVI with self-expanding valves (SEV) has shown improved hemodynamic outcomes and reduced PPM incidence compared to balloon expandable valves (BEV) in patients with extreme SAA. To date, research on inter-racial differences in TAVI among Asian populations is lacking. This multicenter registry aims to evaluate SEV versus BEV outcomes in diverse Asian patients, particularly those with extreme SAA, and to address ethnic-specific challenges in TAVI.
Primary outcome measures
- Bioprosthetic Structural Valve Dysfunction (SVD) at 12 months [Time frame: 12 months Post-Operation]
Secondary outcome measures (10)
- Mortality rate [Time frame: Mortality of patients 12 months post-operation]
- Disabling stroke rate [Time frame: Rate of disabling stroke 12 months post-operation]
- Heart failure re-hospitalization rate [Time frame: Heart failure re-hospitalization rate at 12 month post-operation]
- Rate of moderate prosthesis-patient mismatch (PPM) [Time frame: Rate of moderate prosthesis-patient mismatch (PPM) at 12 month post-operation]
- Rate of severe prosthesis-patient mismatch (PPM) [Time frame: Rate of severe prosthesis-patient mismatch (PPM) at 12 month post-operation]
- Device success rate [Time frame: Device success rate at 30-days post-operation]
- Device safety rate [Time frame: Device safety rate at 30-days post-operation]
- Rate of Bioprosthetic Structural Valve Dysfunction [Time frame: Bioprosthetic Structural Valve Dysfunction (SVD) at follow-up]
- Rate of endocarditis [Time frame: Rate of endocarditis at 12 month]
- Rate of Non-structural valve dysfunction (NSVD) [Time frame: Rate of Non-structural valve dysfunction (NSVD) at 12 month]
Eligibility criteria
Inclusion criteria
- Aortic Stenosis patients treated with Transcatherter Aortic Valve Intervention
Exclusion criteria
- Transcatherter Aortic Valve Intervention for pure Aortic Regurgitation
- Emergent procedure for any reason;
- Previous aortic valve replacement
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Hong Kong
Identifiers
NCT: NCT07240025 · ADAPT-ASIAN